Bernard Durkan (Kildare North, Fine Gael) | Oireachtas source

I support the view expressed by my colleague. We are all concerned that patients in this country have ready access to the best medicine as quickly as possible in line with best international standards. An evaluation has taken place in Europe, which has been undertaken recently in the case of Translarna and a number of other contentious drugs, and I do not know if the same process needs to be undertaken here unless the European evaluation is regarded as being insufficient, a lower standard, not having due regard to the health and safety of patients or something like that.

I seek clarification regarding the Food and Drug Administration in the US. What are the competing drugs in the US market about which the FDA has been concerned? We know that the market place can be protective of products from time to time. What are the competing drugs and does it have any impact on FDA decisions in the US?

I am concerned about the lack of evidence from Europe, and whether the drugs in question may be unsuitable or unsafe. Safety is important. The other issues were dealt with my colleague earlier. The drug is safe or it is not, and I do not think that we need to test it again. It should be obvious that we accept European standards or we do not. If we do not, then we should bring a case to Europe and explain why.

It is a very emotive issue for patients and their families. I fully appreciate the reservations that exist on costs.

I will come to those in a moment, but, from the point of view of the well-being and welfare of the patient and for his or her peace of mind, it is very difficult to explain to a patient and his or her family why a particular drug is not being made available to him or her if it is made available in other jurisdictions. If we have a different set of standards for the examination of drugs, we should tell that to patients.

My understanding is that various drug companies have already offered to talk with the HSE about the cost on a confidential basis. Is that true? If that were the case and given that there is conditional approval, I can see no reason that cannot be done, without commitment to anything else. It would resolve the problem for patients who are distressed at present because of the situation that is ongoing. It would not affect their health because the drugs have already been given conditional approval. Without going into too much detail, what are the conditions of the approval? I presume it is generally based on health and safety grounds and side effects.

I wish to emphasise the point about the duplication of evaluations. There is no case at all for that today. We either have standards that are acceptable at European level or we do not. If we want to have a super standard, in deference to my colleague, then let us set it up and put ourselves on a pedestal above and beyond everybody else but do not let us play around with it. Apart from being an emotive issue, this is a serious issue from the point of view of patients. Depriving them of what they see as being available in other jurisdictions without any difficulty is one they look to us to raise with the experts to see what can be done.

I accept a court case is ongoing and so not much can be said about it at this stage but there can be negotiations off stage, notwithstanding the court case, that could have an impact of a beneficial nature in the interim without any commitment to the future. Could I ask if that could be done in this situation and whether it will be done?